Job Description

• Master's degree in pharmacy, chemistry, or related field with 3+ years of relevant experience.
• Support regional regulatory activities for PDM CMC Project and Commercial Teams, focusing on Small/Synthetic Molecules.
• Assist CMC RA leads in risk identification, ranking, and mitigation plans
• Shadow leads in developing and executing CMC regulatory strategies.
• Under supervision, oversee preparation of CMC regulatory submissions for investigational and commercial products, ensuring compliance with ICH, regional requirements, and company policies.
• Learn to utilize computer systems aligned with business processes within and outside GxP environments.
• Assist in preparing regulatory submissions and interacting with team members, adhering to ICH and regional guidelines.
• Manage document workflows, tracking, indexing, retrieval, and information dissemination within the CMC regulatory department.
• Participate in meetings, providing tactical approaches for issues of low to moderate complexity.
• Contribute to process improvements and participate in other projects as appropriate.
• Learn to interpret regulatory guidelines and ensure compliance with statutory requirements.
• Assist in regulatory impact assessments and technical risk evaluations
• Invest in personal development to acquire regulatory skills and knowledge, with managerial support.
• Develop understanding of CMC regulatory intelligence, guidelines, and trends.

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